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The Supreme Court's Gene Patent Ban: Will It Hurt Research?

Biotech companies cannot patent genes, the Supreme Court ruled this week in a case involving Myriad Genetics and BRCA genes, but it's unclear what long-term effect the ruling will have on genetic research and business decisions.

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FRIDAY, June 14, 2013 — The Supreme Court ruling banning biotech companies from patenting genes struck a blow to the genetic industry, but the long-term impact of the decision is unclear, experts say. While the ruling could lead to new, improved and cheaper genetic tests, experts say, it could also hamper future research — leaving some to question the Court’s decision.

"Myriad did not create anything," Supreme Court Justice Clarence Thomas wrote in the decision. "To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention." One of the criteria for an invention to be patentable is that it cannot be found in nature.

According to Steven Quay MD, PhD, CEO of Atossa Genetic, genes have two components, the exon and the intron. Myriad sequenced the BRCA gene and made a copy of just the exon, so it was considered patentable, he said.

“The BRCA gene as it exists in nature is like all other genes,” Dr. Quay said. “When Myriad sequenced the BRCA gene and made a copy of the exon, they created something that doesn’t exist in nature. Back then, that was sufficient to create a monopoly.” Myriad patented the genes in 1994

That the Supreme Court rejected that idea was not unexpected, he added, and will probably not have an effect in the short term.

“For the patent world, this decision was not a surprise,” he said. “Because this decision was so expected, people didn’t go into the lab today and change the direction of their research.”

Split Decision: Some DNA Is Patentable

While the ruling means biotech firms cannot patent genes, they can patent what they do with them, said Michael Samardzija, PhD, a partner in the intellectual property law firm Bracewell and Giuliani in Hoston, Tex., which is an important distinction.

“Genetic companies are relying less and less on patent claims based on a specific sequence. They usually have a method claim or combination that is not going to be affected by this ruling," Dr. Samardzija said.

However, the decision could severely impact future research, he believes. Without actual gene patents, companies will probably not announce new gene discoveries until they are able to profit from them, which could slow research.

“The point is that if you can’t have patents on the genes you find, researchers aren’t going to want to spend money on that to bring it to the public,” Samardzija said.

Quay agreed that the inability to patent genes may halt scientific advancement. “The value of the patent system is that it spurs innovation,” he said. “Some people attribute the entire industrial success of America to our patent system.

However, the court did not ban patents completely. They ruled that complementary DNA, which is DNA completely sequenced in the lab, can still be patented, because this so-called cDNA is synthesized from scratch. The biotech company Genentech said in a statement that the ruling is the correct one, as it will help drive future research.

“The patent protection that we have for our medicines and diagnostics today largely consists of other types of patents, not patents on naturally occurring DNA,” Genetic said in an emailed request for comment. “Patents are a fundamental foundation of the biotechnology industry, and are necessary to justify the investment, risk-taking and innovation that bring new medicines and diagnostics to patients with serious and life-threatening diseases.”

The ruling will also probably reduce the cost of BRCA testing from $4,000, on average, to mere hundreds, said Susan Klugman, MD, director of reproductive genetics at Montefiore Medical Center in New York City.

In addition, more labs can do research on any and all patented genes without fear of violating a patent.

“People were afraid to do research on some of these genes because of a fear of being sued,” said Dr. Klugman.

But the ultimate effects of the ruling may not be seen for a long time, said Samardzija.

“The US Patent Office said they are going to take a narrow focus to the ruling,” he explained. “They will reject all claims that solely contain DNA sequences, but if it’s a pharmaceutical composition, it may still be accepted. It appears as though there is going to be a limited effect for now.”